A randomized, open-label, comparative trial of BID and TID dosing of saquinavir enhanced oral formulation as part of a triple therapy for advanced AIDS patients

Chetchotisakd, P.; Anunnatsiri, S.; Wankun, J.; Mootsikapun, P.; Boonyaprawit, P.

Journal of the Medical Association of Thailand 85(5): 590-596

2002


ISSN/ISBN: 0125-2208
PMID: 12188390
Document Number: 1348
Objective: To compare the efficacy and safety of 1,400 mg BID and 1,200 mg TID of saquinavir soft gel given with zidovudine and lamivudine in antiretroviral-naive, advanced AIDS patients. Method: A randomized, open-label study conducted at a university hospital. Results: Forty cases were enrolled in the study, 20 cases in each group. The mean CD4 cell count was 29 cells/mm3. The mean log10 HIV-1 RNA was 5.27 copies/mL. Using an on-treatment analysis, the reduction in plasma log10 HIV-1 RNA of BID and TID groups was not statistically significant at -2.44 vs -2.60 copies/mL (-0.16, 95% CI -0.63 to 0.30; p=0.48). The mean increase in CD4 cell counts was not statistically significant at +144 and +159 cells/mm3 (11, 95% CI -75 to 97; p=0.79). Conclusion: The preliminary data suggests that in antiretroviral-naive, advanced AIDS patients, 1,400 mg BID of saquinavir soft gel given with two nucleoside analogues might be as effective as the standard 1,200 mg TID.

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A randomized, open-label, comparative trial of BID and TID dosing of saquinavir enhanced oral formulation as part of a triple therapy for advanced AIDS patients